Holmium for BPH PB-2007973 rev A.pdf

1
Lumenis Holmium
Solutions for
Benign Prostatic Hyperplasia
(BPH)
Bibliography of Published Studies &
Peer-Reviewed Papers
The use of Holmium Laser for surgical
procedures in Benign Prostatic Hyperplasia
(BPH) is clinically based in its versatility for
different cases, improved outcomes, shorter
procedure time, and low complications of the
procedure.
The following list presents selected publications
of the last 10 years, pointing out the advantages
of using Holmium Laser in the surgical treatment
of Benign Prostatic Hyperplasia in Urology.
PB-2007973
rev
A

2
Energy to Healthcare
A Heritage of Innovation
Introduced
› UltraPulse®
CO2
and
VersaPulse®
Holmium
laser systems
Introduced VersaPulse®
C Introduced VersaPulse®
PowerSuite™
, world’s first
100W Holmium laser for
BPH
1990 1996 2000
Introduced
AcuPulse™ with
SurgiTouch
Introduced
VersaPulse P20
Introduced
AcuPulse WaveGuide
Introduced
› AcuPulse DUO
› FiberLase Robotic DIG
› MicroLase Fiber
› FiberLase GYN Handpieces
2009 2010 2012 2012
Introduced
› Lumenis Pulse 120H
› Xpeeda Fiber
› SlimLine 200 D/F/L Fiber
Introduced
› UltraPulse DUO
Introduced
› Suction hand-piece
› OtoLase hand-pieces and fiber
2014 2015 2016
› patented waveguide
delivery system for
CO2
laser.
PB-2007973 rev A

Peer-reviewed publications of using Holmium Laser for Benign Prostatic Hyperplasia (BPH)
Holmium Laser Enucleation of the Prostate (HoLEP).................................................................4
Long-Term Improvement of Clinical Outcomes.........................................................................7
Versatility of Use for Different Prostate Sizes.............................................................................9
Low Post-Operative Complications..........................................................................................10
Benefits of Using Prostate Morcellation Procedure.................................................................12
Holmium Laser Vaporization of the Prostate (HolVAP)..............................................................13
Table of Contents
3
PB-2007973 rev A

Holmium laser enucleation
of the prostate technique for
benign prostatic hyperplasia
Holmium laser
enucleation versus
photoselective vaporization
for prostatic adenoma
greater than 60 ml:
preliminary results
of a prospective,
randomized clinical trial
In 2013, holmium laser
enucleation of the prostate
(HoLEP) may be the new
'gold standard'
› An overview dedicated to explain the techniques for Holmium
laser enucleation of the prostate (HoLEP).
› Holmium laser enucleation of the prostate (HoLEP) is a real
alternative to Transurethral resection of Prostate (TURP) and
open prostatectomy with proven advantages.
› Comparing holmium laser enucleation and high performance
prostate photoselective vaporization for adenomas greater
than 60 ml in 80 patients in two groups.
› A higher maximum flow rate and lower post-void residual
urine were noted in Holmium group. Prostate volume and
serum PSA decreased in 78% and 88% in the holmium
laser group, and 52% and 60% in the vaporization group,
respectively.
› Outcome measures, as maximum flow rate and post-void
residual urine of holmium laser enucleation appear to be
superior to those of photoselective vaporization.
› Assessing why Holmium laser enucleation of the prostate
(HoLEP) has become an important treatment modality for
Benign Prostatic Hypertrophy (BPH).
› The learning curve is actually similar to many other current
urological procedures, and the efficacy of HoLEP is equal to
that of other surgical procedures.
Can J Urol,
19(1):6131-4.
J Urol,
188(1):216-
21.
Curr Urol Rep,
13(6):427-32.
Kelly DC, Das A
Elmansy H, Baazeem
A, Kotb A, Badawy
H, Riad E, Emran A,
Elhilali M
van Rij S, Gilling PJ
2012
2012
2012
Lumenis system
100W
Lumenis system
100W
Lumenis system
Holmium Laser Enucleation of the Prostate (HoLEP)
4
PB-2007973 rev A
Title Publication Authors Year Short summary of study and conclusion Laser system

Long-term results of a
randomized trial comparing
holmium laser enucleation of
the prostate and
transurethral resection of
the prostate: results at 7
years
Evolution and success of
holmium laser enucleation of
the prostate
Comparison of HoLEP and
TURP in terms of efficacy
in the early postoperative
period and perioperative
morbidity
› Assessing the durability of Holmium laser enucleation of
prostate in comparison to Transurethral resection of Prostate
(TURP) in 61 patients in two groups.
› No significant differences in any variable between the two
groups beyond the first year. Of the assessable patients, none
required re-operation for recurrent BPH in the HoLEP arm
and 3 patients out of 17 required re-operation in the TURP
arm.
› HoLEP is at least equivalent to TURP in the long term with
fewer re-operations required in the HOLEP group.
› A Review of the development of instruments, current tech-
nique, and expected outcomes for HoLEP.
› Currently Holmium laser enucleation of the prostate (HoLEP)
is the only procedure with superior outcomes to TURP on
urodynamic studies and long-term studies , and is suitable for
all prostate sizes.
› HoLEP is a safe and effective surgical treatment for
symptomatic BPH, when using high powered laser and
morcellation system.
› Comparing the safety and efficacy of Holmium laser
prostatectomy and Transurethral resection of Prostate (TURP)
in 30 patients with BPH in two groups.
› HoLEP is safe and effective in the surgical management of
benign prostatic hyperplasia, with the advantage of reduced
intraoperative hemorrhage and perioperative morbidity.
BJU Int,
109(3):408-11
Indian J Urol,
26(3):404-9.
Urol Int,
82(2):130-5.
Gilling PJ, Wilson LC,
King CJ, Westenberg
AM, Frampton CM,
Fraundorfer MR
Krambeck AE
Mavuduru RM,
Mandal AK, Singh
SK, Acharya N,
Agarwal M, Garg S,
Kumar S.
2012
2012
2010
Lumenis system
Lumenis system
100W
Lumenis system
5
PB-2007973 rev A

Holmium laser Enucleation
versus transurethral resection
of the prostate: results from
a 2-center prospective
randomized trial in patients
with obstructive benign
prostatic hyperplasia
Three-year Outcome
Following Holmium Laser
Enucleation of the Prostate
Combined with Mechanical
Morcellation in 330
Consecutive Patients
› Multicenter study comparing Holmium laser enucleation of
the prostate (HoLEP) and Transurethral resection of Prostate
(TURP) for Benign Prostate Hyperplasia (BPH) in 100 patients
in two groups.
› Catheterization time and hospital stay were shorter in the
HoLEP group. The overall complication rate was compara-
ble in the 2 groups.
› HoLEP and TURP were equally effective for relieving
obstruction and lower urinary tract symptoms. HoLEP was
associated with shorter catheterization time and hospital stay.
Complications were similar in the 2 groups.
› Assessing safety and efficacy of HoLEP combined with me-
chanical morcellation for bladder outlet obstruction (BOO) due
to benign prostate hyperplasia (BPH) in 330 patients.
› Significant improvements were observed in Urine flow
rate (Qmax=25.1+/-10.7 ml/s), the International Prostate
Symptom Score (IPSS=0.7+/-1.3), and Quality of life scale
(QOL=0.2+/-0.5).
› HoLEP represents an effective and safe surgical intervention,
and could be the standard “size-independent” surgical
treatment for symptomatic bladder outlet obstruction (BOO)
due to BPH.
J Urol, 179(5
Suppl):S87-90.
European
Urology,
53(3):599-604.
Montorsi F, Naspro R,
Salonia A, Suardi N,
Briganti A, Zanoni M,
Valenti S, Vavassori I,
Rigatti P
Vavassori I, Valenti S,
Naspro R, Vismara
A, Dell'Acqua V,
Manzetti A, Hurle R
2008
2008
Lumenis system
Lumenis system
100W
6
PB-2007973 rev A

Long-Term Improvement of Clinical Outcomes
Holmium laser enucleation of
the prostate versus
transurethral resection
of the prostate: a
› Comparing Holmium laser enuclation procedure (HoLEP)
and Transurethral resection of Prostate (TURP) for treat-
ment of BPH in 164 cases.
› In a 12-month follow-up, HoLEP group demonstrated
better scores in Urine flow rate (Qmax), Post-void Residual
urine test (PVR), The International Prostate Symptom
Score (IPSS), and Quality of life scale (QOL).
› Compared with TURP, HoLEP was safer and had better
long-term efficacy as assessed by multiple quantitative
measures
Int Urol
Nephrol,
46(7):1277-82
Sun N, Fu Y, Tian
T, Gao J, Wang Y,
Wang S, An W.
2014 Lumenis system
100W
Holmium laser enucleation
of the prostate: long-term
durability of clinical outcomes
and complication rates during 10
years of follow-up
› Assesing the long-term durability of outcomes and complica-
tion rates after Holmium laser enucleation of the prostate in
949 patients
› All variables improved significantly during the follow-up
period. Postoperative post-void residual volume was 45,
25.7 and 52 ml, mean maximal flow rate was 21.5, 24.3 and
23.4 ml per second, mean International Prostate Symptom
Score was 7.3, 4.4 and 3.8, and mean quality of life was 1.7,
1 and 0.7 (1 month, 1 year and 10 years, respectively). Urge
and stress incontinence were found in a low percentage of
patients (1% and 0.5%, respectively).
› Holmium laser enucleation of the prostate represents an
effective treatment modality for BPH with a low rate of com-
plications during a long follow-up
J Urol;186(5)
:1972-6
Elmansy HM, Kotb A,
Elhilali MM
2011 N/A
7
PB-2007973 rev A

8
PB-2007973 rev A
Holmium
laser enucleation versus
transurethral resection
of the prostate: 3-year
follow-up results of a
› Comparing Holmium laser enuclation procedure (HoLEP)
and Transurethral resection of Prostate (TURP) in a 3-year
follow-up in 200 patients in two randomized groups.
› Post-void Residual urine test (PVR) was better in HoLEP
patients (5.6 versus 19.9 ml). Reoperation rates were 7.2% in
the HoLEP group and 6.6% in the TURP group.
› After a 3 year of follow-up, HoLEP micturition outcomes were
better compaed to TURP. Late complications are equally low.
HoLEP may be a real alternative to TURP.
Eur Urol,
52(5):1456-63.
Ahyai SA, Lehrich K,
Kuntz RM.
2007 Lumenis system
the prostate versus open
prostatectomy for prostates
greater than 100 grams:
5-year follow-up results of a
randomised clinical trial
› 5-year follow-up comparing HoLEP with open prostatectomy
(OP) in 120 patients in two groups.
› Mean Urine flow rate (Qmax) was 24.4 ml/s in both groups,
and Post-void Residual urine test (PVR) was 11 ml in the
HoLEP and 5 ml in the OP group. Reoperation rates were 5%
in the HoLEP and 6.7% in the OP group.
› Five years after the operation, the improvements in micturition
obtained with HoLEP and OP were equally good, and
reoperation rates similarly low. HoLEP seems to be a true
endourological alternative to OP.
Eur Uro,
53(1):160-6.
Kuntz RM, Lehrich K,
Ahyai SA.
2008 Lumenis system
100W
the prostate: results at 6 years
› 6-year follow up in order to assess satisfacion rate and dura-
bility of HoLEP in 71 patients.
› 92% of the patients were either satisfied or extremely satisfied
with their outcome.
› HoLEP is a durable procedure and most patients remain sat-
isfied or extremely satisfied with the long-term outcome.
Eur Urol,
53(4):744-9.
Gilling PJ, Wilson LC,
King CJ, Westenberg
AM, Frampton CM,
Fraundorfer MR.
2008 Lumenis system
100W

PB-2007973 rev A
Holmium Laser Enucleation
of the Prostate for Prostates
Larger Than 175 Grams
Influence of Prostate Size
on the Outcome of Holmium
Laser Enucleation of the
Prostate
of the Prostate Versus
Bipolar Resection of the
Prostate: A Prospective
Randomized Study. "Pros
and Cons"
› Comparing safety, efficacy, and applicability of Holmium
laser enuclation procedure (HoLEP) and Transurethral re-
section of Prostate (TURP) procedure in 120 patients with
BPH with prostate volume of more than 60 cc.
› The International Prostate Symptom Score (IPPS) was
found to be better in the HoLEP group (4.6) versus 5.9 in
the TURP group.
› HoLEP has proved to be effective in treating large pros-
tates with minimal morbidity, better hemostasis, less
blood loss, and better voiding pattern than TURP after a
12-month follow-up.
› Experience with Holmium laser enucleation of the prostate
(HoLEP) for glands larger than 175 cc in 57 patients with
prostate volume range of 175–391 cc.
› Even in the large prostate gland, HoLEP provides a satisfac-
tory outcome with low morbidity. HoLEP is the only endo-
scopic technique that allows for tissue removal comparable to
that of open prostatectomy for such patients.
› Analyzing the effect of prostate size on the outcome of HoLEP
in 354 patients in 3 groups with different prostate weights: 60g
( group 1), 60–100 g (group 2) and >100 g (group 3).
› The mean procedure efficacy increased from 0.36 g/min in
group 1 to 0.49 g/min in group 2 and 0.58 g/min in group 3.
› HoLEP is a safe and effective procedure for treating
symptomatic BPH, independent of prostate size . The efficacy
of HoLEP increases with increasing prostate size.
J Endourol,
24(3):433-7
BJU
International,
101(12):1536-
41
Urology,
86(5):1037-41
Krambeck AE,
Handa SE, Lingeman
JE
Shah HN, Sodha HS,
Kharodawala SJ,
Khandkar AA, Hegde
SS, Bansal MB.
Fayad AS, Elsheikh
MG, Zakaria
T, Elfottoh HA,
Alsergany R,
Elshenoufy A,
Elghamarawy H
2010
2008
2015
Lumenis system
100W
Lumenis system
100W
Lumenis system
100W
Versatility of Use for Different Prostate Sizes
9

PB-2007973 rev A
A Prospective, randomized
clinical trial comparing
plasmakinetic resection of
the prostate with holmium
laser enucleation of the
prostate based on a 2-year
followup
Peri-operative Complications
of Holmium Laser
Enucleation of the Prostate:
Experience in the First 280
Patients, and a Review of
Literature
Experience with more
than 1,000 holmium laser
prostate enucleations for
benign prostatic hyperplasia
› Report of experience with more than 1,000 Holmium laser
enuclation procedures (HoLEP).
› Complications occurred in only 24 cases (2.3%).
› The complication rate is low in Holmium laser prostate
enucleation. Incontinence and the need for ancillary proce-
dures are rare with durable long-term results.
› Comparing plasmakinetic resection with holmium laser enu-
cleation for BPH in 280 patients in 2 groups.
› Patients in the holmium laser enucleation group displayed a
lower risk of hemorrhage, shorter bladder irrigation and cath-
eter times, and shorter hospital stays.
› Plasmakinetic resection and HoLEP of the prostate are effec-
tive and safe treatments for BPH. HoLEP can be applied to
prostates of all sizes, and involves less complications.
› Evaluating complications in 280 patients undergoing Holmium
laser enuclation procedure (HoLEP).
› Transient urinary incontinence was the commonest com-
plication after HoLEP (10.7% of patients) but recovered
spontaneously. A blood transfusion was required during
HoLEP in only one patient.
› Low incidence of complications with HoLEP. Most compli-
cations were minor and easily managed. HoLEP is safe and
reproducible procedure.
J Urol,
189(1):217-22
BJU, 100; 94-
101.
J Urol, 189
(1 Suppl):S
141-5.
Chen YB, Chen Q,
Wang Z, Peng YB,
Ma LM, Zheng DC,
Cai ZK, Li WJ, Ma
LH.
Shah HN, Mahajan
AP, Hegde SS,
Bansal MB.
Amy E. Krambeck,
Shelly E. Handa,
James E. Lingeman
2013
2007
2013
Lumenis system
100W
Lumenis system
100W
Lumenis system
100W
Low Post-Operative Complications
10

of the Prostate: (HoLEP):
Long-Term Results,
Reoperation Rate, and
Possible Impact of the
Learning Curve
› Evaluating long-term outcomes and reoperation rate of
Holmium laser enuclation procedure (HoLEP) in 118 patients.
› Mean maximum flow rate increased from 6.3 to 16.2 ml/s,
mean International Prostate Symptom Score improved
from 17.3 to 5.6. The reoperation rate for recurrent BPH
obstruction was 4.2%.
› Late complications and reoperation rate are very low in
HoLEP procedure. HoLEP represents a safe and effective
treatment for patients with symptomatic enlarged prostate.
European
Urology, 52;
1465- 1472.
Elzayat EA, Elhilali
MM.
2007 Lumenis system
100W
11
PB-2007973 rev A

PB-2007973 rev A
Ex-Vivo Comparison of
Available Morcellation
Devices During Holmium
Laser Enucleation of the
Prostate Through Objective
Parameters
An improved morcellation
procedure for holmium
laser enucleation of
the prostate
Wolf Piranha Versus Lumenis
VersaCut Prostate Morcellation
Devices: A Prospective
Randomized Trial
› Comparing Wolf Piranha and Lumenis® VersaCut™ pros-
tate morcellation devices for patients with BPH undergoing
Holmium laser enuclation procedure (HoLEP) in 74 patients
in two groups.
› Cost analysis favored the VersaCut significantly, despite
the fact the Piranha achieved a slightly non significant high-
er morcellation rate at 5.6 gm per minute compared to the
VersaCut at 4.8 gm per minute.
› Morcellation rates for the two devices are comparable, with
the Piranha having a statistically significant increased cost,
more complicated design and less user-friendly.
› In vitro evaluation of two morcellators (Lumenis VersaCut and
Wolf Piranha) and two nephroscopes during HoLEP.
› For the Wolf and Lumenis morcellators, aspiration power
parameters were 20.4 mL/s and 22.2 mL/s, and morcellating
power parameters were 2.5 g and 6 g of tissue per minute,
respectively.
› The Lumenis morcellator is faster than the Wolf morcellator.
› Modification of the conventional morcellation procedure for
holmium laser enucleation of the prostate (HoLEP) at 395
patients in two groups.
› The improved VersaCut morcellation procedure can be used
in various situations of suction and can be performed in a
more fluent manner and with better efficacy.
J Endourol
28(10):1237-40
J Endourol,
26(12):1625-8.
J Urol,
195(2):413-7
Cornu JN, Terrasa
JB, Lukacs B.
Chen Q, Chen YB,
Wang Z, Peng YB,
Zheng DC, Cai ZK, Li
WJ, Zhou J
El Tayeb MM,
Borofsky MS,
Paonessa JE,
Lingeman JE
2012
2012
2016
Lumenis
VersaCut
Lumenis
VersaCut
Lumenis
VersaCut
Benefits of Using Prostate Morcellation Procedure
12
Title Publication Authors Year Short summary of study and conclusion morcellation
system

PB-2007973 rev A
Initial experience with
new high powered 120W
Holmium for vaporization of
the prostate
Holmium laser for the surgical
treatment of benign prostatic
hyperplasia
› Examination of using a high-powered Holmium laser
system for vaporization of prostate (HolVAP) in 100
patients with BPH
› Post-operatively, American Urology Association score
(AUA), Post-Void Residual Urine Test (PVR), and Urine
flow rate (Qmax) were improved significantly (9.4 versus
24.1, 33 versus 175, and 15.3 versus 8.2, respectively).
Intraoperative visualization and surgeon satisfaction has
been excellent. Patients were treated with no hospital
admission unless other comorbidities were present.
› Experience with HolVAP using 120 W Holmium laser
system has demonstrated significant improvements in
both subjective and objective parameters. The increase
in overall power and advancements in the laser fiber
technology provide greater hemostasis and a shorter
operative time.
› Comparing the outcomes of Holmium laser vaporization of
the prostate (HolVAP) with prostate enucleation (HoLEP) in
198 patients in two groups
› Patients in the HolVAP group had significantly shorter
operative times (77 versus 119 minutes). No significant
differences were found in flow rate outcomes between
groups.
› Both HoLEP and HolVAP are appropriate surgical
procedures for the management of BPH. When performed
correctly, HolVAP technique produces similar results to
HoLEP, and may present a shorter operative time.
Urol Nephrol
Open Access
J 2017, 4(2):
00119
Can J Urol.
,23(4):8356-62.
Beaghler M, Leo
M, Gass J, March
J, Sandoval S,
Wonnaparhown A
Thurmond P, Bose S,
Lerner LB
2017
2016
Lumenis system
120W
Lumenis system
120W
Holmium Laser Vaporization of the Prostate (HolVAP)
13

14
PB-2007973 rev A
Holmium laser ablation
of the prostate (HoLAP):
intermediate-term results of
144 patients
Photoselective laser ablation
of the prostate: a review of the
current 2015 tissue ablation
options
› Review of the physics and the basics behind laser
prostatectomies, as well as to present the most current
literature on vaporization procedure.
› Holmium laser vaporization of prostate (HoLVP) is an
alternative to Transurethral resection of Prostate (TURP) for
small to medium-sized prostates, and recommended in
severely anti-coagulated patients.
› Laser vaporization using Holmium laser is a safe and
effective alternative to TURP in the treatment of benign
prostatic hyperplasia (BPH) for carefully selected patients.
› IAnalyse the intermediate-term outcome of Holmium laser ab-
lation of the prostate (HoLVP) of up to 4 years postoperatively
in 144 patients with BPH.
› International prostate symptom score and quality of life
(IPSS-QoL), maximal flow rate (Qmax) and postvoiding
residual volume (Vres) were significantly improved after 3
months (10.6/18.9 and 80/0, respectively). Re-operation rate
was lower in patients with prostate volume <40 ml.
› HoLVP is a safe and effective procedure for the treatment of
prostates <40 ml. Patients benefit from HoLVP because of a
low bleeding rate and short hospital stay.
World J Urol,
31(5):1253-9
Can J Urol, 22
Suppl 1:45-52.
Barski D, Richter
M, Winter C, Arsov
C, de Geeter P,
Rabenalt R, Albers P
Tholomier C,
Valdivieso R, Hueber
PA, Zorn KC.
2013
2015
Lumenis system
100W
Lumenis system
120W

Holmium laser ablation of
the prostate versus
photoselective vaporization
of prostate 60 cc or less:
short-term results of a
prospective randomized trial
Rapid
communication: holmium
laser ablation of
large prostate glands: an
endourologic alternative to
open prostatectomy
› Comparing holmium laser vaporization and photoselective
vaporization of the prostate in patients with a small to
moderate size prostate in 109 patients in two groups.
› Holmium laser vaporization and photoselective
vaporization of the prostate are safe, effective and easy to
learn in patients with BPH with a small to moderate size
prostate.
› Assessing the efficacy and safety of holmium laser
vaporization of the prostate (HoLVP) in 17 patients with large
glands with a 100 W holmium laser.
› Prostate volume decreased from 121.82 cc to 54.58 cc
(55%). The peak urinary flow rate (Q(max)) increased from
6.92 to 15.06 (217%).
› Because of the excellent hemostatic properties of the
holmium laser wavelength, large glands can be vaporized
safely and efficiently with minimal morbidity.
J Urol,
182(1):133-8.
J Endourol,
21(6):659-62.
Elzayat EA, Al-Mandil
MS, Khalaf I, Elhilali
MM.
Kumar SM
2009
2007
Lumenis system
100W
Lumenis system
100W
15
PB-2007973 rev A

www.lumenis.com/Surgical
ASIA/PACIFIC
Beijing, China
T +86 10 5737 6677
EMEA
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T +91 124 422 07 95
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T +852 217 428 00
F +852 272 251 51
PB-2007973 rev A
Risk information: The use of the Lumenis laser systems, accessories, their delivery devices and Lumenis morcellator in urology is contraindicated for patients who are unable to
receive endoscopic treatments or are intolerant to prolonged anesthesia, as well as for resection or excision of large vascularized organs. Lumenis Holmium laser systems and
accessories are solely intended for use by physicians trained in the use of the Ho:YAG (2.1 μm) wavelength. Incorrect treatment settings can cause serious tissue damage. The
laser should be used only on tissues that are fully observable. See the system user manual for a complete list of contraindications and risks. The use of the Lumenis VersaCut
morcellator and accessories is contraindicated for morcellation of bone and for use in liposuction procedures, Gynecologic surgery in which the tissue to be morcellated is known
or suspected to contain malignancy and removal of uterine tissue containing suspected fibroids in patients who are peri- or post-menopausal, or candidates for en bloc tissue
removal, for example, through the vagina or via a mini-laparotomy incision. Lumenis VersaCut is intended solely for use by physicians trained in the use of the VersaCut morcellator.
The Lumenis VersaCut and accessories should only be used under direct or endoscopic visualization in a fluid environment. See the system user manual for a complete list of
contraindications and risks.

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